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An Efficacy and Safety Study to Compare Morphine 6-glucuronide (M6G) and Morphine in Patients Suffering With Post-Operative Pain for at Least 24 Hours

NCT01082471 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 517

Last updated 2023-08-29

No results posted yet for this study

Summary

To compare the incidence and severity of nausea in the study treatment groups, during the 18-hour period starting 6 hours after titration to pain relief; following confirmation of the assumption of non-inferiority between the two groups of pain relief over the 24 hour post-operative period. Pain relief and nausea will be determined by measuring the areas under the curves of pain intensity and nausea verbal rating scale scores.

Conditions

  • Postoperative Pain

Interventions

DRUG

Morphine 6-glucuronide

DRUG

Morphine

Sponsors & Collaborators

  • Chiltern International Ltd.

    collaborator INDUSTRY

  • HFL Ltd.

    collaborator UNKNOWN

  • Paion UK Ltd.

    lead INDUSTRY

Principal Investigators

  • Alexander Binning, M.D. · Intensive Care Unit, Level 5, Western Infirmary, Glasgow, G11 6NT

  • James Lees, B.Sc. · Paion UK Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-11-30
Primary Completion
2006-11-30
Completion
2006-12-31

Countries

  • Czechia
  • France
  • Germany
  • Netherlands
  • Poland
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01082471 on ClinicalTrials.gov